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effect of addition of Aspirin in oral cancer survival

Randomized control trial of addition of Aspirin to standard care in oral cancer patients.

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052737
Enrollment
60
Registered
2023-05-17
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Aspirin: Aspirin 150 mg PO daily in addition to standard of care till toxicity or recurrence Control Intervention1: Standard of care: Standard of care as per guidelines based on the TNM

Sponsors

Banaras Hindu University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All Histologically proven cases of primary oral cancers. Stage T1 to T4, N0 to N3, M0 to M1. Age above 18. Karnofskyâ?? performance status more than 70, ECOG 0 to 2 Hb above 8.0 gm/dL Total count above 4000 cu mm Platelet count above100000 Serum creatinine less than 1.0mg Liver enzymes up to 1.5 times normal Bilirubin less 1.0mg

Exclusion criteria

Exclusion criteria: Patients with acid peptic disease Pregnant and lactating women. Patients not willing to participate. Patients with known allergy to NSAID Patients with Asthma, rhinitis and nasal polyps Presence of viral fever Use of any other blood thinner like warfarin, heparin or low molecular weight heparin bleeding/blood-clotting disorders (such as hemophilia, vitamin K deficiency, low platelet count) pyruvate kinase or G6PD deficiency Patients receiving mifepristone, acetazolamide, corticosteroids, dichlorphenamide, methotrexate, valproic acid, herbal medications (such as ginkgo biloba) Patients with recent history of anti-viral vaccines

Design outcomes

Primary

MeasureTime frame
safety and toxicity as per WHO toxicity criteria and adverse event monitoringTimepoint: Every 3 weeks

Secondary

MeasureTime frame
Overall survival from the time of diagnosis to deathTimepoint: Common closing date of study;Progression free survival from the time of first diagnosis to local recurrence or metastasisTimepoint: At common closing date

Countries

India

Contacts

Public ContactSumithlal

Banaras Hindu University

mpandey66@bhu.ac.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026